By Counterforce Health Team in Therakos CELLEX (photopheresis system) —

How to Get Therakos CELLEX Photopheresis Covered by Humana in Virginia: Complete Guide to Prior Authorization, Appeals, and Forms

Answer Box: Getting Started

Therakos CELLEX photopheresis requires prior authorization from Humana in Virginia. Your fastest path to approval: 1) Have your specialist submit a prior authorization request through Humana's Availity Essentials portal with complete documentation of steroid-refractory status (for GVHD) or failed systemic therapy (for CTCL), 2) Include medical necessity letter citing NCCN guidelines, and 3) Ensure treatment is scheduled at an approved hospital outpatient infusion center. If denied, you have 65 days to appeal and can request Virginia external review through the State Corporation Commission within 120 days.

Table of Contents

Coverage Requirements at a Glance

Requirement Details Source
Prior Authorization Required for all ECP treatments Humana Provider Portal
Covered Conditions CTCL (mycosis fungoides, Sézary syndrome), steroid-refractory chronic GVHD Medicare NCD 110.4
Site of Care Hospital outpatient infusion centers only Humana Medical Policy
Specialist Oversight Oncologist/dermatologist (CTCL) or transplant specialist/hematologist (GVHD) Prior Authorization Requirements
Review Timeline 30 days standard Humana PA Process
Appeal Deadline 65 days from denial Humana Member Rights

Step-by-Step: Fastest Path to Approval

1. Verify Your Plan Coverage

Who: Patient or clinic staff
Action: Use Humana's prior authorization search tool to confirm ECP requires PA for your specific plan
Timeline: 5 minutes

2. Gather Clinical Documentation

Who: Healthcare team
Documents needed:

  • Complete medical records with diagnosis confirmation
  • Detailed prior treatment history (medications, doses, durations, outcomes)
  • Lab results and imaging studies
  • Specialist consultation notes
    Timeline: 1-2 business days

3. Prepare Medical Necessity Letter

Who: Prescribing specialist
Requirements: Document failed prior therapies, reference NCCN guidelines, explain why ECP is medically necessary
Timeline: 1 business day

4. Submit Through Availity Portal

Who: Provider office
Method: Availity Essentials portal with all supporting documents uploaded
Timeline: Same day submission

5. Track Your Request

Who: Patient and provider
Method: Monitor status through Availity or call Humana provider services
Timeline: Check weekly during 30-day review period

6. Prepare for Potential Peer-to-Peer Review

Who: Prescribing physician
Action: Be ready to discuss case directly with Humana medical director if requested
Timeline: Usually scheduled within 5 business days of request

7. Schedule Treatment Upon Approval

Who: Patient and clinic
Action: Coordinate with approved infusion center for ECP sessions
Timeline: Within 1-2 weeks of approval

Required Forms and Documentation

Core Documentation Package

  • Prior Authorization Request Form (submitted through Availity portal)
  • Medical Necessity Letter from specialist
  • Complete Medical Records including:
    • Pathology reports confirming diagnosis
    • Treatment history with specific drug names, doses, and response
    • Laboratory results and staging information
    • Contraindications to alternative therapies

For CTCL Patients

  • Confirmed diagnosis of mycosis fungoides or Sézary syndrome
  • Documentation of disease unresponsive to at least one prior systemic therapy
  • Staging information and disease progression notes
  • Oncologist or dermatologist consultation

For Chronic GVHD Patients

  • Confirmation of chronic GVHD following allogeneic stem cell transplant
  • Steroid-refractory documentation showing one of:
    • Disease progression within 3-5 days of high-dose steroids (≥2 mg/kg/day)
    • No improvement within 5-7 days of steroid therapy
    • Incomplete response after 28+ days of treatment
  • Transplant specialist or hematologist oversight

Submission Portals and Methods

Primary Method: Availity Essentials Portal

  • URL: Access through Humana provider portal
  • Account Required: Yes, providers must register for Availity access
  • Document Upload: Supports secure upload of clinical records, lab results, and imaging
  • Tracking: Real-time status updates available

Alternative Methods

  • Fax: Available for urgent situations (verify current fax number with Humana)
  • Phone: Provider services line for complex cases requiring clinical intake team consultation
  • Mail: Not recommended due to processing delays
Tip: Always upload documents in PDF format with clear, legible scans. Incomplete or unreadable submissions cause delays.

Appeals Process for Humana in Virginia

Internal Appeals (First Level)

  • Deadline: 65 days from denial notice
  • Method: Submit through member portal or written request
  • Required: Copy of denial letter, additional clinical evidence, updated medical necessity letter
  • Timeline: 30 days for standard review, 72 hours for expedited

Expedited Appeals

Available when delay could seriously jeopardize health:

  • Eligibility: Physician certification of urgent medical need
  • Timeline: 72 hours for decision
  • Documentation: Medical urgency attestation required

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing the specific denial reasons and crafting targeted, evidence-backed rebuttals that align with each payer's own policies and procedures.

Virginia External Review Process

If Humana's internal appeals are unsuccessful, Virginia offers an independent external review through the State Corporation Commission Bureau of Insurance.

Key Details

  • Deadline: 120 days from final internal denial
  • Cost: Free to patients
  • Form: Complete Form 216-A (External Review Request)
  • Contact:

Standard vs. Expedited External Review

  • Standard: Decision within 45 days
  • Expedited: 72 hours for urgent cases (requires Form 216-C and physician certification)

Required Documentation

  • Completed Form 216-A
  • Copy of denial letter
  • Insurance card copy
  • Any additional medical evidence not submitted during internal appeals
Note: Virginia's external review process has a strong track record of overturning wrongful denials when proper medical evidence is presented.

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
"Not medically necessary" Strengthen medical necessity letter with guideline references NCCN guidelines, specialist consultation, treatment failure documentation
"Experimental/investigational" Cite FDA approval and Medicare NCD FDA device approval, Medicare NCD 110.4
"Site of care not appropriate" Confirm treatment at approved facility Hospital outpatient center verification
"Insufficient documentation of steroid failure" Provide detailed steroid trial records Specific medications, doses, durations, objective measures of failure

Clinician Corner: Medical Necessity Letters

Essential Elements for CTCL

  1. Diagnosis confirmation: Pathology report with specific subtype
  2. Prior therapy documentation: List all systemic treatments tried with specific outcomes
  3. Disease progression: Objective measures showing treatment failure
  4. Guideline support: Reference current NCCN guidelines for CTCL
  5. Contraindications: Document why other therapies are inappropriate

Essential Elements for Chronic GVHD

  1. Transplant history: Date and type of allogeneic stem cell transplant
  2. Steroid-refractory status: Specific steroid regimens with doses and response
  3. Organ involvement: Document affected organs and severity
  4. Specialist oversight: Confirm hematologist or transplant specialist involvement
  5. Treatment goals: Expected outcomes from ECP therapy
From our advocates: "We've seen the strongest approvals when clinicians include specific dates, drug names, and objective response measures rather than general statements like 'failed multiple therapies.' Payers want to see the clinical story unfold with precise details."

Approved Treatment Centers

Therakos CELLEX photopheresis must be administered at approved hospital outpatient infusion centers in Virginia. Use Humana's provider directory to locate in-network facilities that offer ECP services.

Requirements for Treatment Centers

  • Hospital-based outpatient infusion center
  • Trained nursing staff experienced with apheresis procedures
  • Emergency protocols and equipment available
  • Humana network participation
Important: Home infusion is not approved for photopheresis treatments due to the complexity of the procedure and safety requirements.

Frequently Asked Questions

How long does Humana prior authorization take in Virginia?
Standard review takes 30 days. Expedited reviews for urgent cases are decided within 72 hours when physician certification of medical urgency is provided.

What if Therakos CELLEX is considered experimental by Humana?
Cite the FDA approval and Medicare National Coverage Determination 110.4, which establishes coverage for ECP in specific conditions including CTCL and steroid-refractory GVHD.

Can I request an expedited appeal if my condition is worsening?
Yes, if your physician certifies that delay could seriously jeopardize your health, you can request expedited internal and external reviews with much shorter timelines.

Does step therapy apply to photopheresis?
Yes, you must typically demonstrate failure of or contraindication to standard therapies before ECP is approved. Document all prior treatments thoroughly.

What happens if my appeal is denied by Humana?
You can request external review through Virginia's State Corporation Commission within 120 days of the final denial. This independent review is free and binding on the insurer.

How do I find an approved treatment center in Virginia?
Use Humana's provider directory to locate in-network hospital outpatient infusion centers. Confirm the facility offers ECP services before scheduling.

Can Counterforce Health help with my appeal?
Yes, Counterforce Health specializes in analyzing denial letters and crafting evidence-backed appeals that address the specific reasons for denial while aligning with payer policies.

What if I have both Medicare and Medicaid coverage?
Coordinate with both payers, as Medicare typically serves as primary coverage for ECP procedures while Medicaid may cover additional costs or copayments.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance plan. Coverage policies and procedures may change. Always verify current requirements with Humana and consult official sources for the most up-to-date information. For personalized assistance with your specific situation, contact Virginia's consumer assistance resources or consider working with specialized advocacy services.

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